Ablation Success With the Use of Steerable AGILIS NxT Introducer Compared With Conventionally Used Swartz SL0.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
研究概览
简要总结
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve.
详细描述
To prove if the success rate of curative treatment of atrial fibrillation in left atrial circumferential pulmonary vein ablation is higher by using a steerable transseptal introducer giving access to the left atrium then by using a conventionally introducer with fixed curve; in patients with paroxysmal or persistent symptomatic Atrial Fibrillation.
Primary Endpoint: rate of patients in stable sinus rhythm at 6 Month Follow Up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or persistent symptomatic atrial fibrillation
- •Resistant to at least 1 anti arrhythmic drug
- •Left atrial diameter less then 60 mm (TTE, parasternal)
- •Atrial fibrillation documented by ECG
- •Patient is willing and available to perform all Follow Ups
排除标准
- •Permanent atrial fibrillation
- •Pre existing left atrial fibrillation ablation
- •Atrial fibrillation due to reversible cause
- •Known intracardiac or other thrombi
- •Pregnancy
- •Women of child bearing potential without negative pregnancy test within 48 hours prior to ablation
- •Contraindication for anticoagulation
结局指标
主要结局
rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter)
时间窗: 6 months post ablation
次要结局
- rate of patients in stable sinus rhythm (free of Atrial Fibrillation and Left Atrial Flutter) at 3 months post ablation rate of pulmonary vein isolation completely isolated rate of complications procedure duration X-ray duration(6 month post ablation)